The invention relates to a device for the transcutaneous implantation of an epicardial pacemaker electrode, which is arranged in a tubular, flexible implantation catheter insertable into the pericardial space.
After the pericardium has been punctured, an implantation catheter of this kind is introduced into the narrow, closed cavity formed between the epicardium and the parietal lamina of the pericardium, called the pericardial cavity or the pericardial space, and is advanced as far as the implantation site. At the implantation site, the epicardial pacemaker electrode, which is composed of an electrically insulated electrode line with one or more non-insulated distal contact points, is anchored in the epicardium/myocardium by means of an active fixing mechanism (e.g. a helix). The electrical impulses emitted from a pacemaker attached to the proximal end of the electrode can be transmitted to the myocardium via the electrode that has been thus fixed, and a controlled stimulation of the heart muscle is thereby triggered.
On account of the need to puncture the pericardium, and because of the very narrow pericardial space, the implantation catheter should have the smallest possible diameter in order to ensure a minimally invasive intervention, to minimize the danger of injury to surrounding organs or organ parts (e.g. pleura, diaphragm, myocardium or coronary vessels) and to permit sufficient spatial manipulation.
EP 2 266 657 A1 discloses an implantable electrode probe with a tubular, flexible probe body, an electrode arranged at the distal end of the probe body, and an electrical supply line guided in the probe body and leading to the electrode, in which a movement mechanism operatively connected to the distal end portion can be transferred from a first state to a second state radially wider than the first state, where it is radially widened in relation to the radial dimension of the rest of the probe body and of the electrode arranged at the distal end of the probe body. In this way, the electrode probe can be implanted with a thin distal end portion through an introducer sheath and vessels, whereas, at the implantation site, the distal end portion of the probe body can be radially widened in order, on the one hand, to provide sufficient perforation protection to prevent tissue perforation by the electrode and, on the other hand, to make available a large surface area for the local release of an active substance at the implantation site.
In order to anchor pacemaker electrodes securely in the epicardium, spiral-shaped or corkscrew-shaped electrodes are known which are screwed into the epicardium/myocardium by means of a device for rotation and insertion of an epicardial/myocardial electrode. The electrode is implanted with the central axis of the spiral electrode perpendicular to the surface of the myocardial tissue, which is achieved, according to DE 60 2004 005 845 T2, by means of a device for rotation and insertion of an epicardial/myocardial electrode line which contains a spiral electrode, an electrode head, an electrode body, an elongate shaft and a rotatable tube arranged rotatably via the elongate shaft, and also a distal element which comprises the electrode head and is coupled pivotably to a distal portion of the elongate shaft and to the rotatable tube, such that, by means of the pivoting of the distal element, the electrode head can be screwed into the myocardial tissue at a predefinable angle.
Using a bulky device of this kind to screw in an epicardial pacemaker electrode is unsuitable on account of the very narrow pericardial space.